EP3015083A1 - Sealing device for sealing a feedthrough for a medical instrument - Google Patents

Abstract

A sealing device (30) for sealing a passage for a medical instrument (20) comprises a fastening region (36) for fastening the sealing device (30) to a tube (10) or another medical device, a ring-like support region (40) is connected to the mounting portion (36) and an annular sealing lip (50) having an outer edge (52) which is connected to an inner edge (44) of the support portion (40) and an inner edge (54) provided and is formed to be in a fluid-tight manner on an outer surface of a shaft (20) inserted into the sealing device (30). The difference (D ₂ -D _S ) of the median diameter (D ₂ ) of the inner edge (44) of the support area (40) and the median diameter (D _S ) of a shaft (20) of a medical instrument for which the sealing device (30 ) and is formed, is not greater than the difference (D _S - D ₁ ) of the average diameter (D _S ) of the shaft (20) and the average diameter (D ₁ ) of the inner edge (54) of the sealing lip (50) (D ₂ -D _S ≤ D _S - D ₁ ).

Description

The present invention is directed to a sealing device for sealing a lead-through for a medical instrument, in particular for sealing the space between a tube and a shaft of a medical instrument disposed in the tube during a micro-invasive medical procedure.

An example of microinvasive medical methods is laparoscopy. A trocar is used to create an artificial access to the abdominal cavity of a patient through the abdominal wall. An endoscope and / or further medical instruments (for example forceps, scissors, needle holders) can be inserted into the abdominal cavity through the lumen of a trocar tube remaining during the laparoscopic procedure in the abdominal wall. During laparoscopy, the abdominal space is filled with carbon dioxide or another gas to create a pneumoperitoneum, a medical interventional cavity. Without special measures, this gas would escape through the tube. Therefore, numerous approaches have been developed to close the lumen of the tube of a trocar as fluid-tight as possible, both in the empty state and when imported instrument.

Partially similar tasks may arise at a working channel of an endoscope or when inserting a catheter into a blood vessel. In the latter case, however, it is not the escape of a gas, but of blood to be prevented.

In US 4,857,062 For example, a valve for introducing a catheter into an artery is described. For sealing a flexible element is provided, which is compressed to form a fluid-tight seal with a catheter.

In WO 93/01850 A1 a lever operated seal for a tube is described. A wall of an elastomer having an opening is stretched by a plurality of levers as an instrument is inserted into the tube, thereby increasing the opening.

In US 5,366,446 there is described an introducer assembly for use on the skin of a patient adapted for the insertion of tubes of different outside diameters. The assembly comprises a membrane of a pierceable elastomeric material in the center of a bellows.

In EP 0 746 359 B1 is described a catheter check valve. To seal a rubber seal with an opening and distal to this duckbill valve with a straight slot provided.

In US 4,430,081 a cannula for use with angiographic catheters is described. For sealing against the ingress of air or leakage of blood from a blood vessel, there are provided a first seal having a slot, a second seal having a hole, and a third seal having a flap therein disposed adjacent to each other.

In WO 91/12838 A1 is an infusion access with a plurality of successively arranged elastic discs, each having circular openings or against each other twisted arranged star-shaped slots provided.

In WO 98/32484 A1 is described a catheter introducer with a hemostasis valve. A sealing element comprises two perforated support discs, between which a

Sealing disc made of soft-elastic foam plastic is provided with radially extending slots.

In US 6,551,282 B1 is a seal for sealing a tube with inserted shaft of an endoscope described. A wide annular seal is surrounded by a stiffer ring.

The sealing devices described each have specific advantages and disadvantages. A very extensive and reliable sealing effect is readily achievable with a sealing lip which presses with the highest possible contact pressure against the outer surface of a shaft of an instrument. However, this results in high sliding and static friction. A thin and / or soft sealing lip produces only slight sliding and stiction, but is not only less robust, but has a reduced effect on a lateral displacement of the shaft in the sealing device.

In all known thin and soft sealing lips, when the direction of movement of a shaft in the sealing device changes, the sealing lip can be tilted, accompanied by a noticeable change in the force acting between the shaft and the sealing device. This change of force can cause an involuntary movement of the shaft, which does not exactly correspond to the will of the medical personnel, which is perceived as disturbing or even endangers the patient.

An object of the present invention is to provide an improved sealing device, which satisfies in particular the enumerated requirements and expectations in balanced proportions.

This object is solved by the subject matters of the independent claims.

Further developments are specified in the dependent claims.

Many conventional sealing devices have as wide a sealing lip as possible to oppose a movement of a shaft of an instrument in the sealing device in a direction orthogonal to the longitudinal axis of the shaft, a low resistance, and to allow for use with shafts of different diameters. Furthermore, the use of wide sealing lips was based on the assumption that, because of their great elasticity, it only offers little resistance to axial movement of a shaft relative to the sealing device. The present invention is based on the recognition that the wide sealing lips offer less of a solution than a problem. Wide sealing lips must have a certain minimum wall thickness in order not to be inflated or deformed, for example, by the overpressure in the pneumoperitoneum. A usability for many different shank diameter then inevitably results in a large mechanical stress at a large shaft diameter, which in turn increases the friction.

Incidentally, movability of a shaft relative to the sealing device in a direction orthogonal to the longitudinal axis of the shaft is achievable not only by wide and elastic sealing lips. In the already mentioned US 6,551,282 B1 is the FIGS. 4 and 5 removable, that said mobility can be ensured by other parts of the sealing device. The same applies to US Pat. No. 7,803,135 B2 , However, it is not apparent in both documents, whether the cognition was known. Anyway, the authors are the US 6,551,282 B1 not deviated from the basic approach of wide sealing lips. The authors of the US Pat. No. 7,803,135 B2 have clearly taken a path that leads away from the approach described below.

Embodiments of the present invention are based on the idea not to allow a displacement of a shaft in a sealing device in a direction orthogonal to the longitudinal axis of the shaft by means of the sealing lip, but to make the sealing lip comparatively narrow. Although said displacement must then be ensured by other measures, but the sealing lip can be made relatively thin without the risk of deformation by a pressure difference. By a surrounding the sealing lip support area with comparatively low elasticity on the one hand and a precise adjustment of the sealing lip to a predetermined shaft diameter, a reliable sealing effect and low friction and only a small force variation when turning the sealing lip to change direction can be achieved.

Embodiments of the present invention further based on the finding that the flipping of the sealing lip after changing the direction of the movement of a shaft in the sealing device is particularly noticeable and disturbing when it occurs simultaneously along the entire circumference of the sealing lip, and this by the usual rotationally symmetrical configuration is favored by sealing devices and their sealing lips. Embodiments of the present invention are therefore based on the idea to break the rotational symmetry of the sealing lip, in order to promote a non-simultaneous, but gradually turning the sealing lip - starting from a point and spreading along its circumference - favor.

A sealing device for sealing a passage for a shaft of a medical instrument comprises a fastening region for attaching the sealing device to a tube or another medical device, a ring-like support region which is connected to the fastening region, and an annular sealing lip with an outer edge which cooperates with is connected to an inner edge of the support portion, and an inner edge which is provided and adapted to be fluid-tight against an outer surface of a shaft inserted into the sealing means, wherein the difference U ₂ - U _{S of} the circumference U _{2 of} the inner edge of the support portion and the circumference U _{S of} a shaft of a medical instrument for which the sealing device is provided and formed, is not greater than the difference U _S - U _{1 of} the circumference U _{S of} the shaft and the circumference U _{1 of} the inner edge of the sealing lip in its tension-free condition (U ₂ - U _S ≤ U _S - U ₁ ) or the difference D ₂ - D _{S of} the mean diameter D _{2 of} the inner edge of the support region and the mean diameter D _{S of} a shaft of a medical instrument, for which the sealing device is provided and formed, is not greater than the difference D _S. - D _{1 of} the mean diameter D _{S of} the shaft and the average diameter D _{1 of} the inner edge of the sealing lip D ₂ - D _S ≤ D _S - D ₁ .

The stated condition for the circumferences can alternatively be formulated such that the arithmetic mean value (U ₁ + U ₂ ) / 2 of the circumference U _{1 of} the inner edge of the sealing lip and the circumference U _{2 of} the inner periphery of the support portion is not larger than the circumference U _{S of} a stem of a medical instrument for which the seal is provided and formed ((U ₁ + U ₂ ) / 2 ≦ D _S ). The mentioned condition for the average diameter can alternatively be formulated so that the arithmetic mean (D ₁ + D ₂₎ / 2 of the average diameter D ₁ of the inner edge of the sealing lip and the mean diameter D ₂ of the inner edge of the support portion is not greater than the mean diameter D _{S of} a shaft of a medical instrument, for which the sealing device is provided and formed.

A sealing device for sealing a passage for a shaft of a medical instrument comprises a fastening region for attaching the sealing device to a tube or another medical device, a ring-like support region which is connected to the fastening region, and an annular sealing lip with an outer edge which cooperates with an inner edge of the support portion, and an inner edge provided and adapted to be fluid-tight against an outer surface of a shaft inserted into the sealing device, the circumference of the inner edge of the sealing lip being at least six-tenths and at most nine-tenths of the circumference a shaft of a medical instrument for which the sealing device is provided and designed

A sealing device for sealing a passage for a shaft of a medical instrument comprises a fastening region for attaching the sealing device to a tube or another medical device, a ring-like support region which is connected to the fastening region, and an annular sealing lip with an outer edge which cooperates with an inner edge of the support portion is connected, and an inner edge which is provided and adapted to be fluid-tight against an outer surface of a shaft inserted into the sealing device, wherein the average thickness of the sealing lip is in particular at most one fifth of the average thickness of the support region.

In the case of the sealing devices described here, the sealing lip is in each case in particular membrane-like. In particular, the sealing lip has a constant thickness or one in radial Direction and / or in the circumferential direction only slightly (in particular by a factor of two or less) varying thickness.

Insofar as the inner edges of the support portion and the sealing lip and the outer contour of the cross section of the stem of a medical instrument for which the sealing device is provided and formed are each circular, the average diameters are equivalent to the diameters and conditions for the circumferences and the diameters , As the mean diameter of an edge, which differs from the shape of a circle only in portions which together make up less than half or less than one third of the circumference of the rim, the diameter of the circle is considered. As the average diameter of another non-circular edge, the diameter of a circle whose area corresponds to the content of the area bounded by the edge is considered.

If the support region and the sealing lip have the same material and are formed in one piece and there is no stepwise change in thickness between the support region and the sealing lip, the inner edge of the support region is the (linear) set of the locations where the force acting on the sealing device a deformation by a shaft of a medical instrument, for which the sealing device is provided and designed, contrary, strongly increases. The inner edge of the support region is, for example, the (linear) set of locations at which the force that opposes the seal to deformation by a shank of a medical instrument for which the sealing device is provided and formed is doubled or tripled from the minimum value or fivefold or tenfold. The inner edge of the support region is in particular the line at which the thickness of the sealing device corresponds to the arithmetic mean of the minimum thickness of the sealing lip and the maximum thickness of the support region or 90% of the thickness of the support region. In particular, when the support portion has the shape of a ring-like portion of a constant-thickness plate and continuously merges into the sealing lip, the inner edge of the support portion is the inner edge of the plate-shaped portion of constant thickness. The outer edge of the support area is, for example, where the support area in a substantially cylindrical wall or passes directly into a mounting area.

The sealing device is provided in particular for sealing the annular or ring-like gap between the inner surface of a tube of a trocar and the outer surface of a tube of a medical instrument arranged in the tube. The medical instrument is, for example, an endoscope or other medical instrument for use in microinvasive medical procedures. The sealing device is provided and designed for a medical instrument having a shaft with a predetermined cross section, in particular with a circular cross section with a predetermined diameter. In order to avoid confusion or inadvertent use for a shank cross-section for which the sealing device is not provided and designed, the sealing device can be clearly identified with an alphanumeric lettering, a symbol or a color. In particular, the shaft diameter, for which the sealing device is provided and configured, may be indicated alphanumerically on the sealing device.

The support region and the sealing lip may have the same material, in particular the entire sealing device is integrally formed, for example as a casting, which comprises the fastening region, the support region and the sealing lip. Alternatively, the sealing lip on the one hand and the support region and / or the attachment region on the other hand may comprise different materials, wherein regions of different materials are in particular material and / or form-fitting connected to each other. For example, the sealing lip of a comparatively soft material and the support region or a part of the support region or the cylindrical wall 38 are formed of a comparatively hard material.

The attachment region comprises, for example, an inwardly projecting collar on the distal or the patient and the tube to be turned edge, which can form a positive mechanical connection with a groove on the proximal or the sealing device facing the edge of a tube or other medical device.

The sealing device is in particular partially or completely formed from a silicone elastomer, another elastomer or another elastic material. The material of the sealing device or at least the material of the sealing lip in particular has a hardness of about 40 Shore A. The elasticity of the material, in particular in the attachment region, can allow the formation and release of a positive mechanical connection of the sealing device with a tube or another medical device.

A support region or a sealing lip is ring-like if the support region or the sealing lip has the topology of a circular ring, that is to say it is doubly coherent in the mathematical sense. Neither the annular support area nor the annular sealing lip must be annular. The inner and outer edges of the support region and the sealing lip may each be circular, elliptical, oval, polygonal or have another shape.

A sealing device with the described features can have a very narrow sealing lip, that is to say a sealing lip in which the difference between the diameters or the difference of the peripheries of the outer and inner margins is small, without a lateral displacement of a shaft inserted into the sealing device To effect cancellation of the sealing effect. A narrow sealing lip can in turn be designed to be particularly thin-walled and particularly elastic without impairing the sealing effect. A thin-walled and elastic configuration of the sealing lip can reduce the friction between the sealing lip and a shaft and minimize the effect of flipping the sealing lip when the direction of movement of a shaft in the sealing direction is reversed.

In the case of a sealing device as described here, the sealing lip is, in particular, not rotationally symmetrical with respect to the longitudinal axis of a shaft inserted in the intended middle position and orientation into the sealing device.

A sealing device for sealing a passage for a shaft of a medical instrument comprises a fastening region for fastening the sealing device on a tube or other medical device, and an annular sealing lip having an inner edge provided and adapted to be fluidly in contact with an outer surface of a shaft inserted into the sealing device, the sealing lip not being rotationally symmetric about the longitudinal axis of a central position provided and orientation inserted into the sealing device shaft.

The longitudinal axis of a shaft in the case of a shaft with a straight and circular cylindrical surface is the axis of symmetry of this surface. The intended mean position and orientation of a shaft in the sealing device results from the geometry of the sealing device. For example, the distal edge and / or the fastening device near the distal edge of the sealing device is rotationally symmetrical to the longitudinal axis of a shaft inserted into the intended middle position and orientation in the sealing device. Furthermore, the position and orientation of the longitudinal axis of a shaft inserted in the intended central position and orientation into the sealing device are usually predetermined by the tube or medical device (in particular its axis of symmetry) for which the sealing device is provided and designed.

As an alternative to the fact that the sealing lip is not rotationally symmetrical with respect to the longitudinal axis of a shaft inserted in the intended central position and orientation in the sealing device, the sealing lip can not be rotationally symmetrical to the longitudinal axis of a shaft inserted into the sealing device in the mechanical stress-reduced state of the sealing device.

A non-rotationally symmetrical design of the sealing lip can have the consequence that forces acting in the sealing lip and mechanical stresses and forces acting between the sealing lip (in particular its inner edge) and an outer surface of a shaft vary along the inner edge of the sealing lip. This in turn can cause a gradual, from a location on the inner edge of the sealing lip and extending from there relatively slowly spreading flipping the sealing lip in a reversal of the direction in which a shaft is moved in the sealing device. The effect of folding, which is also known by users of conventional sealing devices as Snap is called, it can be significantly reduced. This may allow for a more sensitive movement of a shaft of a medical instrument in the sealing device and reduce the risk of involuntary movement or movement of a shaft in the sealing device that does not exactly correspond to the will of the medical personnel and resulting injury to a patient.

In particular, a sealing device as described here further comprises an annular support region which is connected to the fastening region, wherein an outer edge of the sealing lip is connected to the inner edge of the support region.

In a sealing device, as described here, in particular at least either the inner edge or the outer edge of the sealing lip is not circular.

In a sealing device, as described here, in particular the center of the area bounded by the inner edge of the sealing lip surface is spaced from the surface center of the limited by the outer edge of the sealing lip surface.

In a sealing device, as described here, the sealing lip, in particular in the mechanically tension-free state, has a thickness which varies in the direction of its circumference.

In the case of a sealing device as described here, in particular the surface normals of two surfaces of the sealing lip facing away from one another are not parallel at positions lying opposite one another on the surfaces in the mechanically tension-free state of the sealing lip.

The surface normals of two mutually remote surfaces of the sealing lip at opposite locations on the surfaces in particular include an angle in the range of 1 degree to 3 degrees or in the range of 1.5 degrees to 2 degrees. The described non-parallelism of the surface normal is present in particular for the entire surface of the sealing lip or for at least half of the surface of the sealing lip.

In a sealing device, as described here, the inner edge of the sealing lip in particular the shape of a section of a lateral surface of a cylinder whose axis of symmetry is not parallel to the mean surface normal of two mutually remote surfaces of the sealing lip, on.

The inner edge of the sealing lip has in particular the shape of a section of a lateral surface of an oblique circular cylinder or of another cylinder. The symmetry axis, i. the direction of translational invariance of the lateral surface of the cylinder includes, in particular, an angle of at least 5 degrees or at least 10 degrees or at least 20 degrees or at least 30 degrees with the mean surface normal of two surfaces facing away from each other. The average surface normal is, in particular, the mean value or half the difference between the normalized integrals of the surface normal via the two surfaces of the sealing lip facing away from one another.

In a sealing device, as described here, the inner edge of the sealing lip is in particular rounded, for example with a circular arc-shaped cross section.

In a sealing device, as described here, the sealing lip in particular has a continuously increasing from the inner edge of the sealing lip to the outside thickness.

In the case of a sealing device as described here, the mean surface normal of the sealing lip is in particular not parallel to the longitudinal axis of a shaft inserted in the intended middle position and orientation into the sealing device.

The mean surface normal of the sealing lip is in particular the normalized integral of the surface normal of one of two mutually remote surfaces of the sealing lip over the entire sealing lip. Alternatively, the average surface normal, for example, the average or half the difference of the normalized integrals of the surface normal over the two mutually remote surfaces of the sealing lip. The angle between the mean surface normal and the longitudinal axis of a shaft inserted in the intended middle position and orientation into the sealing device is in particular at least 5 degrees or at least 10 degrees or at least 20 degrees or at least 30 degrees.

In a sealing device as described here, the support region is in particular parallel or substantially parallel to a plane which is not parallel to the longitudinal axis of a shaft inserted into the intended middle position and orientation in the sealing device.

The entire support region or a proximal surface region and / or a distal surface region of the support region may in each case essentially have the shape of a-in particular annular-cutout of a plane whose normal is not parallel to the longitudinal axis of a shaft inserted into the intended middle position and orientation in the sealing device is.

Furthermore, the entire support region or a proximal surface region and / or a distal surface region of the support region can each have the shape of a - in particular annular - section of a curved surface, for example a spherical surface or a surface of another ellipsoid of revolution.

Each of the described (and combinable) types of non-rotationally symmetrical design of the sealing lip can cause a variation of the forces between the sealing lip and the surface of an inserted shaft and / or the mechanical stress within the sealing lip, the gradual instead of a simultaneous flipping of the sealing lip Change the direction of movement of a shaft in the sealing device can result. The sealing lip is always provided and designed to abut - along with a circumferential line on the outer surface of an inserted shaft - unlike a seal with one or more radial sections and thus to develop a complete or very extensive sealing effect.

In a sealing device as described herein, the circumference of the inner edge of the sealing lip is at least six tenths and at most nine tenths of the circumference a shaft of a medical instrument, for which the sealing device is provided and formed.

In particular, in a sealing device as described herein, the inner edge of the sealing lip is substantially circular, and the diameter of the inner edge of the sealing lip is at least six tenths and at most nine tenths of the diameter of a circular cylindrical shaft of a medical instrument for which the sealing device is provided and designed.

The circumference or diameter of the inner edge of the sealing lip may alternatively be at least seven tenths and / or at most eight tenths of the circumference or diameter of a shaft for which the sealing device is provided and designed.

If the shape of the inner edge of the sealing lip only partially deviates from an ideal circular shape, the diameter of the inner edge of the sealing lip is meant in particular the diameter of the circle.

A ratio of the peripheries or diameters of the inner edge of the sealing lip and the outer contour of the cross section of a shaft for which the sealing device is provided and formed in the range of six or seven tenths to eight or nine tenths can be a particularly favorable compromise between good and allow reliable sealing effect on the one hand and low friction between the shaft and sealing device on the other.

In a sealing device, as described here, the average thickness of the sealing lip is in particular at most one fifth of the average thickness of the support region.

The thickness of the sealing lip is in particular about 0.3 mm. A ratio of the thickness of the sealing lip to the thickness of the support region of at most 1: 5 creates on the one hand an elastic sealing lip and a low friction between the sealing lip and inserted shank and on the other hand a sufficiently rigid or rigid or inelastic support region to a complete or extensive sealing effect even then to ensure if an in The shaft arranged in the sealing device is displaced in a direction orthogonal to its longitudinal axis relative to the sealing device. A sufficient rigidity of the support region in this case means that the complete annular support region is displaced as soon as the shaft has completely deformed the sealing lip on one side and bears against the support region. Due to the resulting complete displacement of the support region, it can be ensured that the sealing lip still bears completely against the shaft on the opposite side and can completely fulfill its sealing effect. This applies in particular if the conditions described apply simultaneously to the differences in perimeters or diameters or to the arithmetic mean of the perimeters or diameters.

In the case of a sealing device as described here, a displacement of the support region relative to the fastening region, for example due to an elasticity of a tubular wall of the sealing device connecting the support region to the fastening region, may be possible. Alternatively, the sealing means may be provided and formed for connection to a tube or other medical device which allows displacement of the entire sealing means.

In the case of a sealing device as described here, in particular one of two surfaces of the sealing lip facing away from one another is flush with one of two surfaces of the supporting region facing away from one another.

In particular, the proximal surfaces of the sealing lip and the support area facing away from a tube or another medical device with which the sealing device is to be connected are flush. For example, both proximal surfaces lie in one plane or on a spherical surface or a surface of another ellipsoid of revolution. Alternatively, the distal or a tube or other medical device to which the sealing device is to be joined may face surfaces of the sealing lip and support region in one plane, on a spherical surface or another rotational ellipsoid surface, or be otherwise flush.

The flush design of surfaces of the sealing lip and the support region can simplify their production, in particular the shape of a casting tool used. A conical or other funnel-shaped configuration of a transition region between the proximal surfaces of the support region and the sealing lip can facilitate insertion of a shaft of a medical instrument into the sealing device.

In a sealing device, as described here, the sealing lip in the mechanically tension-free state has in particular the shape of a section of a plane, a surface of a circular cone or an elliptical cone, a surface of a pyramid, a surface of a paraboloid of revolution or another Paraboloid or from a surface of a sphere or other ellipsoid of revolution or another ellipsoid.

The sealing lip is in particular in the mechanically tension-free state when no shaft of a medical instrument is inserted into the sealing device. The shape of the sealing lip in the mechanically tension-free state is in particular the shape of the sealing lip after the manufacture of the sealing device and before its use. In particular, the sealing lip has the shape of a ring-like or doubly coherent section of a plane or a surface of a circular cone, an elliptical cone, a pyramid, a paraboloid or ellipsoid. If the sealing lip has the shape of a section of a surface of a pyramid, the base of the pyramid in particular a smooth (in the mathematical sense differentiable) or polygonal edge.

In a sealing device, as described here, in particular at least a part of the surface of the sealing lip is friction-reduced coated or designed.

A friction-reducing coating of the sealing device comprises in particular poly (p-xylylene), which is also marketed under the brand name Parylene.

A friction-reducing coating or design of the sealing lip may be used for moving a medical instrument in the sealing device to overcome the Reduce stiction and / or the sliding friction forces required and beyond prevent reversal of the direction of movement folding over the sealing lips. Further, a friction-reducing coating or design of the surface may assist in gradually folding over the sealing lip upon a change in the direction of movement of a shaft in the sealing device. A reduced friction by the coating can further reduce the risk of damage or destruction of the sealing device, for example when inserting a pointed or sharp-edged medical instrument.

A tube has a sealing device as described here.

The tube is in particular the tube of a trocar.

Brief description of the figures

• Figur 1 eine schematische Darstellung eines Schnitts durch eine Dichteinrichtung;
• Figur 2 eine weitere schematische Darstellung eines Schnitts durch die Dichteinrichtung aus Figur 1;
• Figur 3 eine weitere schematische Darstellung eines Schnitts durch die Dichteinrichtung aus Figuren 1 und 2;
• Figur 4 eine weitere schematische Darstellung eines Schnitts durch die Dichteinrichtung aus Figuren 1 bis 3;
• Figur 5 eine schematische Darstellung eines Schnitts durch eine weitere Dichteinrichtung;
• Figur 6 eine schematische Darstellung eines Schnitts durch eine weitere Dichteinrichtung;
• Figur 7 eine schematische Darstellung eines Schnitts durch eine weitere Dichteinrichtung;
• Figur 8 eine schematische Darstellung eines Schnitts durch eine weitere Dichteinrichtung;
• Figur 9 eine schematische Darstellung eines Schnitts durch eine weitere Dichteinrichtung;
• Figur 10 eine schematische Darstellung eines Schnitts durch eine weitere Dichteinrichtung;
• Figur 11 eine schematische Darstellung eines Schnitts durch eine weitere Dichteinrichtung;
• Figur 12 eine schematische Darstellung eines Schnitts durch eine weitere Dichteinrichtung;
• Figur 13 eine schematische Darstellung eines Schnitts durch eine weitere Dichteinrichtung;
• Figur 14 eine schematische Draufsicht auf eine weitere Dichteinrichtung;
• Figur 15 eine schematische Draufsicht auf eine weitere Dichteinrichtung;
• Figur 16 eine schematische Draufsicht auf eine weitere Dichteinrichtung;
• Figur 17 eine schematische Draufsicht auf eine weitere Dichteinrichtung;
• Figur 18 eine schematische Darstellung eines Schnitts durch eine weitere Dichteinrichtung.

Embodiments are explained in more detail with reference to the accompanying figures. Show it:

• FIG. 1 a schematic representation of a section through a sealing device;
• FIG. 2 a further schematic representation of a section through the sealing device FIG. 1 ;
• FIG. 3 a further schematic representation of a section through the sealing device Figures 1 and 2 ;
• FIG. 4 a further schematic representation of a section through the sealing device FIGS. 1 to 3 ;
• FIG. 5 a schematic representation of a section through a further sealing device;
• FIG. 6 a schematic representation of a section through a further sealing device;
• FIG. 7 a schematic representation of a section through a further sealing device;
• FIG. 8 a schematic representation of a section through a further sealing device;
• FIG. 9 a schematic representation of a section through a further sealing device;
• FIG. 10 a schematic representation of a section through a further sealing device;
• FIG. 11 a schematic representation of a section through a further sealing device;
• FIG. 12 a schematic representation of a section through a further sealing device;
• FIG. 13 a schematic representation of a section through a further sealing device;
• FIG. 14 a schematic plan view of another sealing device;
• FIG. 15 a schematic plan view of another sealing device;
• FIG. 16 a schematic plan view of another sealing device;
• FIG. 17 a schematic plan view of another sealing device;
• FIG. 18 a schematic representation of a section through another sealing device.

Description of the embodiments

FIG. 1 shows a schematic representation of a section through a sealing device 30 for sealing a passage for a shaft of a medical instrument. The cutting plane of the FIG. 1 includes an axis of symmetry to which the sealing device 30 is rotationally symmetrical.

The sealing device 30 is designed for mechanical connection to a tube 10 of a trocar or to another medical device. The tube 10 is not part of the sealing device 30 and therefore in FIG. 1 only transparent and indicated by dashed contours. The sealing device 30 has a proximal or from the trocar 10 and in the use of a side facing away from a patient 32 and a distal or the trocar 10 facing edge 34. At or near the distal edge 34, an inwardly projecting collar 36 for engaging a corresponding groove on the trocar 10 is provided. A cylindrical wall 38 connects the distal edge 34 with the inwardly projecting collar 36 on the one hand to the proximal side 32 of the sealing device 30 on the other.

The proximal side 32 of the sealing device 30 is formed by an annular support region 40 and a sealing lip 50. The support region 40 and the sealing lip 50 each have the shape of an annular cutout of a plate. The outer edge 42 of the support portion 40 merges into the cylindrical wall 38 of the sealing device 30. The inner edge 44 of the support portion 40 is connected by a transition region 60 with the outer edge 52 of the sealing lip 50. The inner edge 54 of the sealing lip 50 is provided for abutment with a shaft of a medical instrument to be inserted into the sealing device 30.

In the illustrated example, the distal or the tube 10 facing and in FIG. 1 each downwardly oriented surfaces of the support portion 40 and the sealing lip 50 are flush and are in particular in a plane. The proximal or away from the tube 10 and in FIG. 1 upwardly oriented surfaces of the support portion 40 and the sealing lip 50 lie in two spaced-apart planes. The transition region 60 therefore has a conical proximal surface.

The sealing device 30 is in particular formed in one piece as simultaneously produced with all the features described casting. The sealing device 30 has, for example, a silicone elastomer or another elastomer or another elastic material. The material of the sealing device 30 has in particular a hardness of about 40 Shore-A. In the mentioned rotational symmetry of the sealing device 30, the outer edge 42 and the inner edge 44 of the support portion 40 and the outer edge 52 and the inner edge 54 of the sealing lip 50 are each circular, with all centers lie on the axis of symmetry of the sealing device 30.

The inner edge 54 of the sealing lip 50 has a diameter D ₁ . The inner edge 44 of the support portion 40 has a diameter D ₂ . The sealing device 30 is intended and designed for use with a shaft of a medical instrument, which has a diameter D _S. The diameters D ₁ and D _{2 of} the inner edges 54, 44 of the sealing lip 50 and the support portion 40 are selected such that D ₂ -D _S ≦ D _S -D ₁ . In other words, the arithmetic mean (D ₁ + D ₂ ) / 2 is not larger than the median diameter D _{S of} a stem of a medical instrument for which the sealing device 30 is provided and formed. A similar condition (equivalent for circular edges 54, 44 and cross-section) is U ₂ -U _S ≦ U _S -U ₁ , where U _{1 is} the circumference of the inner edge 54 of the sealing lip 50, U _{2 is} the circumference of the inner edge 44 of the support region 40 and U _{S is} the circumference of a shaft of a medical instrument for which the sealing device is provided and designed. This condition is mathematically identical with the condition that the arithmetic mean (U ₁ + U ₂ ) / 2 of the circumference U _{1 of} the inner edge 54 of the sealing lip 50 and the circumference U _{2 of} the inner edge 44 of the support portion 40 is not larger than that Circumference U _{S of} the shaft, (U ₁ + U ₂ ) / 2 ≤ U _S.

To ensure the above relations between the diameters or circumferences, as based on the FIGS. 2 to 4 is shown, at any time a complete sealing effect.

The diameter D _{1 of} the inner edge 54 of the sealing lip 50 is between 60% and 90% of the diameter D _{S of} a stem of a medical instrument for which the sealing device is provided and formed, 0.6 D _S ≦ D ₁ ≦ 0.9 D _S. This also contributes to the sealing effect.

The sealing lip 50 has a thickness t ₁ . The support region 40 has a thickness t ₂ . The cylindrical wall 38 has a thickness t ₃ . The thickness t _{1 of} the sealing lip 50 is at most one fifth of the thickness t _{2 of} the support region 40, t ₁ / t ₂ ≦ 1/5. With this thickness ratio is ensured that the sealing lip 50 has a much greater elasticity than the support portion 40. This contributes, as shown in the FIGS. 2 to 4 shown, as well as that the sealing effect of the sealing device 30 even under adverse circumstances preserved. For example, the thickness t _{1 of} the sealing lip 50 is approximately 0.3 mm and the thickness t _{2 of} the support region 40 is approximately 1.5 mm.

FIG. 2 shows a further schematic sectional view of the sealing device 30 from FIG. 1 , The type of representation, in particular the sectional plane shown, corresponds to that of FIG. 1 , In difference to FIG. 1 the sealing device 30 is shown without a tube. In difference to FIG. 1 is in FIG. 2 a shaft 20 of a medical instrument in the sealing device 30 is shown. The shaft 20 has a longitudinal axis 28, which coincides in the illustrated situation with the axis of symmetry of the sealing device 30 and lies in the illustrated sectional plane.

The inner edge 54 of the sealing lip 50 abuts against the outer surface of the shaft 20 in a region surrounding the shaft 20 in an annular manner. As a result, the sealing lip 50 unfolds the intended sealing effect. Since the diameter D _{S of} the shaft 20 is greater than the diameter D _{1 of} the inner edge 54 of the sealing lip 50 in its mechanically tension-free state (see. FIG. 1 ), the sealing lip 50 is deformed. The resulting mechanical stress within the sealing lip 50 causes a contact pressure of the sealing lip 50, in particular its inner edge 54, on the outer surface of the shaft 20. This contact pressure promotes the sealing effect, but also generates sliding and static friction between the sealing lip 50 and the shaft 20th . Due to the small thickness t ₁ of the seal lip 50 are the contact pressure of the sealing lip 50 on the outer surface of the shaft 20, and the friction between these relatively low.

In the FIG. 2 shown deformation of the sealing lip 50 results in particular during insertion of the shaft 20 from proximal to distal or in FIG. 2 from top to bottom. After a reversal of the direction of movement of the shaft 20 relative to the sealing device 30 and a movement of the shaft 20 relative to the sealing device 30 proximally, the sealing lip 50 can be folded, after which the inner edge 54 of the sealing lip 50 is no longer distally, but oriented proximally. This transfer is perceived by the medical personnel as being snapped and may cause an involuntary or not exactly the will of the medical personnel corresponding movement of the shaft 20. This can pose a risk of injury to a patient. By the low Thickness of the sealing lip 50, the forces occurring during the folding of the sealing lip 50 are relatively low.

FIG. 3 shows a further schematic representation of a section through the sealing device 30 from the Figures 1 and 2 , The type of representation, in particular the sectional plane corresponds to that of FIG. 1 and especially those of FIG. 2 ,

In difference to FIG. 2 shows FIG. 3 a situation in which the shaft 20 is displaced relative to the sealing device 30 in a direction orthogonal to the longitudinal axis 28 of the shaft 20 and to the axis of symmetry of the sealing device 30. The shaft 20 is displaced as far as it is possible with maximum deformation of the sealing lip 50 and without substantial deformation of the support portion 40 maximum. Due to the relationship described between the diameters D ₁ , D ₂ and D _{S of} the inner edges 54, 44 of the sealing lip 50 and the support portion 40 and the shaft 20, the sealing lip 50 is also located at the maximum deformation opposite, in FIG. 3 left side still on the outer surface of the shaft 20 at. This further ensures a complete sealing effect.

FIG. 4 shows a further schematic representation of a section through the sealing device 30 from the FIGS. 1 to 3 , The type of representation, in particular the sectional plane corresponds to that of FIG. 1 and especially the FIGS. 2 and 3 ,

In FIG. 4 a situation is shown in which the shaft 20 relative to the sealing device 30 even further than in the FIG. 3 shown situation is shifted in the direction orthogonal to the longitudinal axis 28 of the shaft 20. It is at the in FIG. 4 illustrated example, the cylindrical wall 38 deformed. Alternatively or additionally, the in FIG. 1 indicated, in FIG. 4 not shown tube 10 are deformed. The large thickness t _{2 of} the support portion 40 and its resulting low mechanical elasticity cause the support portion 40 not only at the location of maximum deformation of the sealing lip 50 (in FIG FIG. 4 : right), but also on the opposite side (in FIG. 4 : left) is shifted in the same or almost the same amount. The sealing lip 50 is therefore not only in place maximum deformation, but also on the opposite side still completely on the outer surface of the shaft 20 and unfolds its full sealing effect.

The basis of the FIGS. 2 to 4 illustrated sealing effect of the sealing device 30 even with significant displacement of the shaft 20 is in particular when t ₁ / t ₂ ≤ 1/5, because then the sealing lip 50 is sufficiently elastic and the support portion 40 is sufficiently inelastic.

FIG. 5 shows a schematic representation of a section through a further sealing device 30, which in some features, properties and functions of the basis of the FIGS. 1 to 4 The sealing device shown is similar. The type of representation, in particular the sectional plane corresponds to that of FIGS. 2 to 4 and especially the FIG. 1 , wherein neither a tube nor a shaft of a medical instrument are indicated. In the following, particular features and properties are described in which the in FIG. 5 shown sealing device 30 from the basis of FIGS. 1 to 4 differs illustrated sealing device.

At the in FIG. 5 the sealing lip 50 is arranged relative to the support region 40 further proximally (in the figures: above). In particular, the proximal surface of the sealing lip 50 is arranged flush with the proximal surface of the support region 40. The proximal surfaces of the sealing lip 50, the support region 40 and the transition region 60 thus lie in one plane. The transition region 60 has a conical distal surface.

FIG. 6 shows a schematic representation of a section through another sealing device 30, which in some features, properties and functions based on the FIGS. 1 to 5 Similar to illustrated sealing devices. The type of representation corresponds to that of the FIGS. 1 to 4 and especially the FIG. 5 , Particular features, properties and functions are shown below, in which the in FIG. 6 shown sealing device from the basis of FIGS. 1 to 5 differs illustrated sealing devices.

At the in FIG. 6 Sealing device 50 shown, the sealing lip 50 is arranged relative to the support portion 40 so that neither the proximal surfaces nor the distal surfaces of the sealing lip 50 and the support portion 40 are flush or lie in a plane. Instead, the transition region 60 has conical surfaces both proximally and distally.

FIG. 7 shows a schematic representation of a section through another sealing device 30, which in some features, properties and functions based on the FIGS. 1 to 6 Similar to illustrated sealing devices. The type of representation corresponds to that of the FIGS. 1 to 4 and especially the FIGS. 5 and 6 , Particular features, properties and functions are shown below, in which the in FIG. 7 shown sealing device from the basis of FIGS. 1 to 6 differs illustrated sealing devices.

In the FIG. 7 illustrated sealing device differs in particular from the in FIG. 1 in particular characterized in that the proximal surface of the transition region 60 between the sealing lip 50 and support portion 40 is not conical, but more generally funnel-shaped, but with a rounded transition to the outer edge 52 of the sealing lip 50 is formed. The inner edge 44 of the support region 40 is defined by a sharp edge to the transition region 60. Alternatively or additionally, a soft transition to the transition region 60 may be provided on the inner edge 44 of the support region 40. Accordingly, the conical distal surfaces of the transition region 60 in the basis of Figures 5 and 60 embodiments shown to be rounded.

FIG. 8 shows a schematic representation of a section through another sealing device 30, which in some features, properties and functions based on the FIGS. 1 to 7 Similar to illustrated sealing devices. The type of representation corresponds to that of the FIGS. 1 to 4 and especially the FIGS. 5 to 7 , Particular features, properties and functions are shown below, in which the in FIG. 8 shown sealing device from the basis of FIGS. 1 to 7 differs illustrated sealing devices.

In the FIG. 8 illustrated sealing device 30 differs from the basis of the FIGS. 1 to 7 Sealing devices shown in particular in that the sealing lip 50, the shape of an annular section of a cone or circular cone 72, the in FIG. 8 is indicated in dashed lines, has. The tip of the circular cone 72 points distally to facilitate insertion of a shaft of a medical instrument into the sealing device by a centering action.

In the illustrated example, the outer edge 52 of the sealing lip 50 is disposed between two planes defined by the proximal and distal surfaces of the support portion 40. Therefore, both the proximal and the distal surfaces of the transition region 60 each have a conical shape similar to that of FIG FIG. 6 illustrated sealing device.

The proximal surface of the sealing lip 50 is flush with the proximal surface of the transition region 60. The proximal surfaces of the sealing lip 50 and the transition region 60 enclose the same angle with the longitudinal axis 28 of a shaft inserted in the intended middle position and orientation in the sealing device 30.

FIG. 9 shows a schematic representation of a section through another sealing device 30, which in some features, properties and functions based on the FIGS. 1 to 8 Similar to illustrated sealing devices. The type of representation corresponds to that of the FIGS. 1 to 4 and especially the FIGS. 5 to 8 , Particular features, properties and functions are shown below, in which the in FIG. 9 shown sealing device from the basis of FIGS. 1 to 8 differs illustrated sealing devices.

In the FIG. 9 shown sealing device 30 differs from the basis of the FIGS. 1 to 8 illustrated sealing devices in particular characterized in that the sealing lip 50 has no constant thickness. Rather, the thickness of the sealing lip 50 varies in the direction of its circumference. In the illustrated example, the proximal and distal surfaces of the sealing lip 50 are each flat, with the surface normals at an angle of approximately 1.5 Include degrees. Since the in FIG. 9 sectional plane shown is selected so that the surface normals of both surfaces of the sealing lip 50 lie in the cutting plane are in FIG. 9 (right) the minimum thickness and (left) the maximum thickness of the sealing lip 50 visible.

FIG. 10 shows a schematic representation of a section through another sealing device 30, which in some features, properties and functions based on the FIGS. 1 to 9 Similar to illustrated sealing devices. The type of representation corresponds to that of the FIGS. 1 to 4 and especially the FIGS. 5 to 9 , Particular features, properties and functions are shown below, in which the in FIG. 10 shown sealing device from the basis of FIGS. 1 to 9 differs illustrated sealing devices.

In the FIG. 10 illustrated sealing device 30 differs from the basis of the FIGS. 1 to 9 in particular shown in that the sealing lip 50 has a width varying along its circumference. For example, both the outer edge 52 and the inner edge 54 of the sealing lip 50 are each circular, wherein the centers of both edges 52, 54 are spaced from each other. In the illustrated example, the center of the inner edge 54 of the sealing lip 50 is located on the longitudinal axis 28 of a shaft inserted in the intended middle position and orientation in the sealing device 30.

FIG. 11 shows a schematic representation of a section through another sealing device 30, which in some features, properties and functions based on the FIGS. 1 to 10 Similar to illustrated sealing devices. The type of representation corresponds to that of the FIGS. 1 to 4 and especially the FIGS. 5 to 10 , The following are features, properties and functions in which the in FIG. 11 shown sealing device from the basis of FIGS. 1 to 10 differs illustrated sealing devices.

In the FIG. 11 shown sealing device 30 differs from that of the FIG. 10 illustrated sealing device in particular in that the sealing lip 50 is not like at the basis of the Figures 5 and 10 Sealing devices shown flush with the proximal surface of the support portion 40, but similar to the reference to the FIGS. 1 to 4 . 7 and 9 shown sealing means is arranged flush with the distal surface of the support portion 40. Furthermore, the in FIG. 11 shown sealing device 30 from the basis of FIG. 10 illustrated in that the inner edge 54 of the sealing lip 50 is positioned eccentrically. For example, the inner edge 44 of the support portion 40, the outer edge 52 and the inner edge 54 of the sealing lip 50 are each circular, wherein the centers of the inner edge 44 of the support portion 40 and the outer edge 52 of the sealing lip 50 on a in FIG. 11 Not shown symmetry axis of the sealing device 30 are. The center of the inner edge 54 of the sealing lip 50 and thus the longitudinal axis 28 of an inserted into the intended mean position and orientation in the sealing device 30 shaft are spaced from the symmetry axis of the sealing device 30.

FIG. 12 shows a schematic representation of a section through another sealing device 30, which in some features, properties and functions based on the FIGS. 1 to 11 Similar to illustrated sealing devices. The type of representation corresponds to that of the FIGS. 1 to 4 and especially the FIGS. 5 to 11 , Particular features, properties and functions are shown below, in which the in FIG. 12 shown sealing device from the basis of FIGS. 1 to 11 differs illustrated sealing devices.

In the FIG. 12 shown sealing device 30 differs from the basis of the FIGS. 1 to 11 Sealing devices shown in particular in the embodiment of the inner edge 54 of the sealing lip 50. In the basis of FIGS. 1 to 11 illustrated embodiments, the inner edge 54 is indicated in each case with the shape of a narrow annular section of a lateral surface of a circular cylinder, wherein the axis of symmetry of the circular cylinder coincides with the longitudinal axis 28 of an inserted in the intended central position and orientation in the sealing device 30 shaft. At the in FIG. 12 shown sealing means 30, the inner edge 54 of the sealing lip 50 has the shape of a narrow annular section of a lateral surface one in FIG. 12 indicated by dashed lines cylinder 78, whose axis of symmetry (ie direction of translational invariance) is not parallel to the longitudinal axis 28 of an inserted in the intended middle position and orientation in the sealing device 30 shaft of a medical instrument. Rather, the symmetry axis of the cylinder 78 and the longitudinal axis 28 enclose an angle, for example, in the range of 15 degrees to 45 degrees, and in particular is about 30 degrees.

FIG. 13 shows a schematic representation of a section through another sealing device 30, which in some features, properties and functions based on the FIGS. 1 to 12 Similar to illustrated sealing devices. The type of representation corresponds to that of the FIGS. 1 to 4 and especially the FIGS. 5 to 12 , Particular features, properties and functions are shown below, in which the in FIG. 13 shown sealing device from the basis of FIGS. 1 to 12 differs illustrated sealing devices.

In the FIG. 13 shown sealing device 30 differs from the basis of the FIGS. 1 to 12 in particular characterized in that the sealing lip 50 is not parallel to a plane orthogonal to the longitudinal axis 28 of an inserted in the intended middle position and orientation in the sealing device 30 shaft. The sealing lip 50 is instead tilted. In the illustrated example, the outer edge 52 of the sealing lip 50 on one side (in FIG. 13 : left) with the distal surface of the support region 60 and on the opposite side (in FIG. 13 : right) flush with the proximal surface of the support portion 60.

FIG. 14 shows a schematic plan view of a sealing device 30, which in some features, properties and functions based on the FIGS. 1 to 13 Similar to illustrated sealing devices. The drawing plane of the FIG. 14 is orthogonal to the cutting planes of the FIGS. 1 to 13 and to the longitudinal axis 28 of an inserted in the intended middle position and orientation in the sealing device 30 shaft. The sealing device 30 is shown in a proximal view, so that the proximal side 32 (see FIG. FIGS. 1 to 13 ) is visible. The contour of the inner surface of the cylindrical wall 38 of the sealing device 30 is indicated by a dashed line.

In the illustrated example, the cylindrical wall 38 of the sealing device 30 has the shape of a section of a lateral surface of a circular cylinder, the contours of its cross section are therefore each circular. Also, the inner edge 44 of the support portion 40 and the outer edge 52 of the sealing lip 50 are each circular, with all the circle centers are on the longitudinal axis 28 of an inserted in the intended middle position and orientation in the sealing device 30 shaft. Notwithstanding this far-reaching rotational symmetry of the sealing device, a tongue 56 is provided on the sealing lip 50, which protrudes into the opening enclosed by the sealing lip 50 for a shaft. The inner edge 54 of the sealing lip 50 therefore has a shape which deviates in the region of the tongue 56 from a pure circular shape.

FIG. 15 shows a schematic representation of a plan view of another sealing device 30, which in some features, properties and functions based on the FIGS. 1 to 14 Similar to illustrated sealing devices. The type of representation corresponds to that of the FIG. 14 , Particular features, properties and functions are described below, in which the in FIG. 15 shown sealing device 30 from the basis of FIGS. 1 to 14 differs illustrated sealing devices.

At the in FIG. 15 Sealing device 30 shown, the sealing lip 50 has a broadened like area 58 area. The outer edge 52 of the sealing lip 50 and the inner edge 44 of the support portion 40 have on or adjacent to the book-like widened portion 58 of the sealing lip on a shape deviating from a circular shape. The inner edge 54 of the sealing lip 50 is circular.

FIG. 16 shows a schematic representation of a plan view of another sealing device 30, which in some features, properties and functions based on the FIGS. 1 to 15 Similar to illustrated sealing devices. The type of representation corresponds to that of the FIGS. 14 and 15 , The following describes characteristics, properties and functions in which the in FIG. 16 shown sealing device 30 from the basis of FIGS. 1 to 15 differs illustrated sealing devices.

At the in FIG. 16 The inner edge 44 of the support portion 40, the outer edge 52 and the inner edge 54 of the sealing lip 50 each have the shape of a circle, wherein the centers of the inner edge 44 of the support portion 40 and the outer edge 52 of the sealing lip 50 opposite the symmetry axis of other features of the sealing device 30 and in particular with respect to the center of the inner edge 54 of the sealing lip 50 are shifted. The sealing lip 50 therefore has similar to the reference to the FIGS. 10, 11 . 14 and 15 illustrated sealing means on a varying width along its circumference.

FIG. 17 shows a schematic representation of a plan view of another sealing device 30, which in some features, properties and functions based on the FIGS. 1 to 16 Similar to illustrated sealing devices. The type of representation corresponds to that of the FIGS. 14 to 16 , The following describes characteristics, properties and functions in which the in FIG. 17 shown sealing device 30 from the basis of FIGS. 1 to 16 differs illustrated sealing devices.

At the in FIG. 17 shown sealing means 30, the inner edge 44 of the support portion 40, the outer edge 52 and the inner edge 54 of the sealing lip 50 each have the shape of an ellipse, wherein the surface centers of the ellipses on the axis of symmetry of other features of the sealing device 30 and the longitudinal axis 28 of an in the intended mean position and orientation in the sealing device 30 inserted stem lie. In the illustrated example, the major major axes of the elliptical inner edge 44 of the support portion 40 and the elliptical outer edge 52 of the sealing lip 50 are parallel to the minor major axis of the elliptical inner edge 54 of the sealing lip 50 and the minor major axes of the elliptical inner edge 44 of the support portion 40 and the elliptical outer edge 52 of the sealing lip 50 parallel to the major axis of the elliptical inner edge 54 of the sealing lip 50. The sealing lip 50 therefore has a continuously varying width along its circumference.

FIG. 18 shows a schematic representation of a section through another sealing device 30, which in some features, properties and functions based on the FIGS. 1 to 17 Similar to illustrated sealing devices. The type of representation corresponds that of the FIGS. 1 to 4 and especially the FIGS. 5 to 13 , Particular features, properties and functions are shown below, in which the in FIG. 18 shown sealing device from the basis of FIGS. 1 to 17 differs illustrated sealing devices.

In the FIG. 18 shown sealing device 30 differs from the basis of the FIGS. 1 to 12 in particular characterized in that the sealing lip 50 is not parallel to a plane orthogonal to the longitudinal axis 28 of an inserted in the intended middle position and orientation in the sealing device 30 shaft. This resembles the in FIG. 18 shown sealing device 30 of the basis of FIG. 13 illustrated sealing device.

In contrast to the basis of the FIGS. 1 to 12 illustrated sealing devices and in contrast to the basis of the FIG. 13 However, shown sealing device is in the in FIG. 18 30, the support region 40 is not arranged in a plane orthogonal to the longitudinal axis 28 of a shaft inserted in the intended middle position and orientation in the sealing device 30. Rather, both the support portion 40 and the sealing lip 50 are parallel or substantially parallel to a plane which is tilted relative to the longitudinal axis 28, respectively. In the illustrated example, the normal of a plane to which the support portion 40 and the sealing lip 50 are parallel or substantially parallel encloses an angle in the range of 5 with the longitudinal axis 28 of a shank inserted into the intended middle position and orientation in the sealing means 30 Degrees to 10 degrees. However, the angle may alternatively be less than 5 degrees or greater than 10 degrees.

In the case of the FIGS. 1 to 18 illustrated sealing devices, in particular with reference to the FIGS. 1 to 13 and 18 illustrated sealing devices, the support areas are each formed as annular cutouts of flat plates. The support areas thus each have a flat or substantially planar proximal surface area and a flat and substantially planar distal surface area, which are parallel to each other. Deviating from this, the entire support areas or the proximal surface areas and / or the distal surface areas of the Support areas each having the shape of annular cutouts of curved surfaces, for example, of spherical surfaces or surface of other ellipsoids of revolution.

In the FIGS. 1 to 18 , especially in the FIGS. 1 to 13 and 18 , the cross sections are each indicated as homogeneous. The illustrated sealing devices 30 thus each consist of a single material, which forms both the support region 40 and the sealing lip 50 and in particular also the cylindrical wall 38 and the inwardly projecting collar 36 (as a fastening region). Deviating from this, each of the illustrated sealing devices can consist of a plurality of different materials, wherein regions of different materials are in particular materially and / or positively connected with each other. For example, the sealing lip of a comparatively soft material and the support region or a part of the support region or the cylindrical wall 38 are formed of a comparatively hard material.

In the case of the FIGS. 9 to 18 illustrated sealing means 30, the sealing lips 50 are each not rotationally symmetrical to the longitudinal axis 28 of an inserted in the intended middle position and orientation in the sealing device 30 shaft. The deformation of the sealing lip 50 by a shaft inserted into the sealing device 30 - similar to the FIG. 2 Therefore, causes an elastic deformation and an associated mechanical stress within the sealing lip 50 and a contact pressure of the sealing lip 50 on the outer surface of the shaft, which are not rotationally symmetrical, but vary along the circumference of the sealing lip 50. As a result, when the direction of movement of a shaft in the sealing device 30 is reversed, a gradual instead of a sudden and simultaneous folding or folding over of the sealing lip 50 may be favored. A gradual turning of the sealing lip 50 is - among other things depending on the friction between the sealing lip 50 and the outer surface of the shaft - for example, from the point at which the sealing lip 50 has the greatest width or the smallest thickness and spreads from this location starting along the circumference of the sealing lip until the sealing lip 50 completely is turned down. The gradual flipping of the sealing lip 50 is less noticeable and is perceived by medical personnel as less disturbing.

At all by the FIGS. 1 to 18 Sealing means shown, the entire surface or at least a part or more parts of the surface of the sealing lip 40 friction-reducing coated or designed. For example, the entire surface or part of the surface of the sealing lip 40 may be coated with poly (p-xylylene), which is also marketed under the trade name Parylene. A friction-reducing coating can reduce static friction and / or sliding friction between the sealing device 30 and a medical instrument inserted into the sealing device 30.

Characteristics of the basis of the FIGS. 1 to 18 shown sealing devices are partially combined with each other. For example, in the basis of the FIGS. 9 to 18 Sealing devices shown, the sealing lips and the transition areas similar to those based on the FIGS. 5 to 8 be arranged and formed sealing means shown. Furthermore, an asymmetrical configuration of the sealing lip 50 may be similar to that described with reference to FIGS FIGS. 9 to 18 shown present when sealing lip 50 and support portion 40 are not clearly distinguishable from each other, but for example, with a common wedge-shaped cross-section continuously merge into each other.

reference numeral

10

Tube of a trocar

20

medical instrument or stem of a medical instrument

28

Longitudinal axis of the shaft 20

30

sealing device

32

proximal side of the sealing device 30

34

distal edge of the sealing device 30

36

inwardly projecting collar on the distal edge 34 of the sealing device 30

38

cylindrical wall of the sealing device 30 between the distal edge 34 and the support area 40

40

Supporting region of the sealing device 30

42

outer edge of the support area 40

44

inner edge of the support area 40

50

Sealing lip of the sealing device 30

52

outer edge of the sealing lip 50

54

inner edge of the sealing lip 50

56

Tongue of the sealing lip 50

58

bay-like widened region of the sealing lip 50

60

Transition region between support area 40 and sealing lip 50

72

cone

74

inner or distal surface of the sealing lip 50

76

outer or proximal surface of the sealing lip 50

78

cylinder

Claims (13)

A sealing device (30) for sealing a passage for a shaft (20) of a medical instrument, comprising: a mounting portion (36) for attaching the sealing device (30) to a tube (10) or other medical device; a ring-like support portion (40) connected to the attachment portion (36); an annular sealing lip (50) with an outer edge (52) which is connected to an inner edge (44) of the support portion (40) and an inner edge (54) which is provided and formed to a at an outer surface in a fluid-tight manner to the shaft (20) introduced into the sealing device (30), being at least either the difference (U ₂ -U _S ) of the circumference (U ₂ ) of the inner edge (44) of the support region (40) and the periphery (U _S ) of a stem (20) of a medical instrument for which the sealing device (30) is provided and is formed, is not greater than the difference (U _S - U ₁ ) of the circumference (U _S ) of the shaft (20) and the periphery (U ₁ ) of the inner edge (54) of the sealing lip (50) in its de-energized state (U ₂ -U _S ≦ U _S -U ₁ ) or the difference (D ₂ -D _S ) of the mean diameter (D ₂ ) of the inner edge (44) of the support portion (40) and the average diameter (D _S ) of a shaft (20) of a medical instrument, for which the sealing device (30) is provided and formed, is not greater than the difference (D _S - D ₁ ) of the average diameter (D _S ) of the shaft (20) and the average diameter (D ₁ ) of the inner Rands (54) of the sealing lip (50) (D ₂ -D _S ≤ D _S - D ₁ ). A sealing device (30) according to the preceding claim, in which
the sealing lip (30) is not rotationally symmetrical with respect to the longitudinal axis (28) of a shaft (20) introduced into the intended middle position and orientation in the sealing device (30). A sealing device (30) for sealing a passage for a shaft (20) of a medical instrument, comprising: a mounting portion (36) for attaching the sealing device (30) to a tube (10) or other medical device; an annular sealing lip (50) having an inner edge (54) provided and adapted to be fluid tight against an outer surface of a shaft (20) inserted into the sealing device (30), wherein the sealing lip (50) is not rotationally symmetrical to the longitudinal axis (28) of a shaft (20) inserted in the intended central position and orientation in the sealing device (30). Sealing device (30) according to one of claims 2 and 3, in which
at least either the inner edge (54) or the outer edge (52) of the sealing lip (50) is non-circular . Sealing device (30) according to one of claims 2 to 4, in which
the area center of the surface bounded by the inner edge (54) of the sealing lip (50) is spaced from the center of the area defined by the outer edge (52) of the sealing lip (50). Sealing device (30) according to one of claims 2 to 5, in which
the sealing lip (50) in the mechanically tension-free state has a varying thickness in the direction of its circumference. A sealing device (30) according to the preceding claim, in which
Surface normals of two mutually remote surfaces of the sealing lip (50) at opposite locations on the surfaces in the mechanically tension-free state of the sealing lip (50) are not parallel . Sealing device (30) according to one of claims 2 to 7, in which
the inner edge (54) of the sealing lip (50) has the shape of a section of a lateral surface of a cylinder whose axis of symmetry is not parallel to the average surface normal of two mutually facing away surfaces (74, 76) of the sealing lip (50). Sealing device (30) according to one of claims 2 to 8, in which
the mean surface normal of the sealing lip (50) is not parallel to the longitudinal axis (28) of a shaft (20) inserted in the intended central position and orientation in the sealing device (30). Sealing device (30) according to one of the preceding claims, in which
the circumference of the inner edge (54) of the sealing lip (50) is at least six tenths and at most nine tenths of the circumference of a stem (20) of a medical instrument for which the sealing device (30) is provided and formed. Sealing device (30) according to one of the preceding claims, in which
the average thickness (t ₁ ) of the sealing lip (50) is at most one fifth of the average thickness (t ₂ ) of the support region (40). Sealing device (30) according to one of the preceding claims, wherein the sealing lip (50) in the mechanically tension-free state has a continuously varying thickness in the direction of its circumference. Tube (10) with a sealing device (30) according to one of the preceding claims.

Images